PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives
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ClinicalTrials.gov Identifier: NCT00948402 |
Recruitment Status :
Completed
First Posted : July 29, 2009
Last Update Posted : October 14, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Polycystic Ovarian Syndrome Insulin Sensitivity | Drug: Metformin Drug: oral contraceptive | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | December 2006 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: metformin |
Drug: Metformin
metformin 1250 mg three times daily
Other Name: Biguanides |
Active Comparator: oral contraceptive |
Drug: oral contraceptive
30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
Other Name: estroprogestins |
- PED/PEA-15 protein expression [ Time Frame: 6 months ]
- BMI, plasma glucose, plasma insulin, insulin sensitivity indexes (1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI, whole-body insulin sensitivity index). [ Time Frame: 6 months ]

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Ages Eligible for Study: | 21 Years to 28 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- female
- premenopausal
- obesity
- PCOS.
Exclusion Criteria:
- pregnancy
- type 2 diabetes or impaired glucose tolerance
- hypothyroidism
- hyperprolactinaemia
- Cushing's syndrome
- nonclassical congenital adrenal hyperplasia
- previous (within the last 6 months) use of oral contraceptives
- glucocorticoids
- antiandrogens
- ovulation induction agents
- antidiabetic and antiobesity drugs, or other hormonal drugs.
None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948402
Principal Investigator: | Annamaria Colao, MD PhD | Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples |
Responsible Party: | Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples |
ClinicalTrials.gov Identifier: | NCT00948402 |
Other Study ID Numbers: |
NeuroendoUnit-11 |
First Posted: | July 29, 2009 Key Record Dates |
Last Update Posted: | October 14, 2009 |
Last Verified: | October 2009 |
PED/PEA-15 protein PCOS IR |
metformin OCP Oral Contraceptive |
Polycystic Ovary Syndrome Insulin Resistance Hypersensitivity Syndrome Disease Pathologic Processes Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ovarian Cysts Cysts Neoplasms |
Ovarian Diseases Adnexal Diseases Gonadal Disorders Endocrine System Diseases Metformin Biguanides Contraceptive Agents Contraceptives, Oral Hypoglycemic Agents Physiological Effects of Drugs Reproductive Control Agents Contraceptive Agents, Female |